Efficacy and Safety of Vildagliptin Compared to Placebo i... | NCT00101712

Studies
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

NCT00101712

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

274Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptin
Vildagliptin Placebo

Countries

Germany
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Jan 12, 2005

First Submission Date that Met QC Criteria

Jan 12, 2005

First Posted Date

Jan 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

Description Module

Brief Summary

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vildagliptin	Experimental		Drug: vildagliptin
Placebo	Placebo Comparator		Drug: Vildagliptin Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vildagliptin	Drug		Vildagliptin	LAF237
Vildagliptin Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in HbA1c at 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Adverse event profile after 52 weeks of treatment
Patients with HbA1c <6.5% at 12 weeks
Patients with HbA1c <6.5% at 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Blood glucose criteria must be met
Not currently on drug therapy for type 2 diabetes
Body mass index (BMI) in the range 22-45
Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion Criteria:

Pregnancy or lactation
Type 1 diabetes
Evidence of serious diabetic complications
Evidence of serious cardiovascular complications
Significant laboratory abnormalities as defined by the protocol
Other protocol-defined exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Investigative Site			Germany
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18248490	Derived	Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Jauffret S, Foley JE. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia*. Diabetes Obes Metab. 2008 Aug;10(8):675-82. doi: 10.1111/j.1463-1326.2008.00850.x. Epub 2007 Nov 22.
17925336	Derived

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000077597	Vildagliptin
C475520	1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring